Trans-Abdominis Plane Block Efficacy for Post-Cesarean Section Pain: A Randomized Double-Blinded Case Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Difference in pain perception based upon VAS scores at rest between blocked and unblocked side in each subject
研究概览
简要总结
The primary aim of this study is to measure the magnitude and duration of trans-abdominis plane (TAP) block analgesia in parturients undergoing elective cesarean section with concurrent standard of care operative analgesic regimens including intrathecal morphine sulfate (ITMS). A one sided block model takes advantage of the bilateral nature of the pain created by a bilateral surgical wound and allows each patient to serve as her own control. Reduced variability allows a more definitive establishment of analgesic benefit for this block.
The current reports of conflicting data regarding efficacy make uncertain the role of TAP block in post cesarean section pain relief. This model would have a better potential for measuring the block's effectiveness. Quantitative sensory evaluation tools such as the von Frey hair tool provides a quantitative reproducible measure of skin sensation and also allows for assessment of block regression over time. Pressure algometry has been established as a clinical and research tool for quantitative assessment of pain levels in multiple pain conditions. A useful inexpensive reliable pressure algometer has recently been described.
The assessment of serum ropivicaine levels with this block will provide useful data regarding the systemic absorption of local anesthetic compared to other peripheral nerve blocks and establish the safety of the technique.
In addition this study will help establish a model for the study of TAP block modifications in the future. If block effectiveness is demonstrated, this model can be used to examine numerous block parameters including choice of local anesthetic and dose response analysis for optimal volume and concentration. Potential future study may be done also in the area of adjuncts found to have increased duration and effectiveness as used in other peripheral nerve blocks.
Expected duration of this study is 18 months.
详细描述
This will be a randomized, double-blinded prospective trial. Group A patients will be randomized to receive a TAP block with local anesthetic on the right, sham block on the left. Group B be will randomized to receive the reverse. The study population will be limited to healthy parturients undergoing elective caesarian section with spinal anesthesia (SAB) or combined spinal-epidural anesthesia (CSE) placed in the operating room at time of surgery.
Patient recruitment:
Prior to enrollment into the study informed consent will be obtained. Consent will be obtained by a study investigator blinded to the group into which the patient will be randomized. After preanesthetic counseling and patient agreement for a SAB or CSE for cesarean delivery will counsel the patient regarding study participation. Pre-operative instruction of the VAS scale shall be given by the investigator. Routine pre-operative preparations per current protocols will occur.
Intra-operative Anesthetic Regimen:
Anesthetic techniques will be per current protocols. A single intravenous infusion will be used for both intraoperative infusion of intravenous fluids during anesthetic maintenance infusion and for blood sampling for ropivicaine levels following TAP block placement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton pregnancy
- •Pre-pregnancy body mass index less than or equal to 35
- •Elective repeat cesarean section under SAB or CSE (patients in whom the epidural catheter is activated intra-operatively will be excluded)
- •English-Speaking patient
- •Age at least 18 and no more than 40 years old.
排除标准
- •Chronic pain or daily consumption of pain medications
- •Neurologic disorders producing altered sensory perception or impaired motor strength in lower extremities or abdomen
- •Pre-existing epidural analgesia infusion for labor analgesia.
- •Spinal anesthetic failure requiring epidural catheter use or general anesthesia
- •Intra-operative conversion to general anesthesia for fetal indications.
- •Cesarean section performed with a vertical (not Phannenstiel) incision
研究组 & 干预措施
right side
The trans-abdominis block will be placed in every pat with one side being injected with ropivicaine, the other side placebo injection. Hence is subject can serve as their own control. Subjects will receive additional pain medications as needed
干预措施: placebo (Drug)
Left side
The trans-abdominis block will be placed in every pat with one side being injected with ropivicaine, the other side placebo injection. Hence is subject can serve as their own control. Subjects will receive additional pain medications as needed
干预措施: ropivicaine (Drug)
结局指标
主要结局
Difference in pain perception based upon VAS scores at rest between blocked and unblocked side in each subject
时间窗: 4, 6, 8, 12, 16, 20 and 24 hours post TAP placement
次要结局
- Duration of time at pain perception between sides is equal(4, 6, 8, 12, 16, 20, and 24 hours post TAP)
- Duration of time skin sensation of touch(4, 6, 8, 12, 16, 20, and 24 hours post TAP)
- Difference in pain perception(4, 6, 8, 12, 16, 20, and 24 hours post TAP)
- Assessment of ropivacaine levels(4, 6, 8, 12, 16, 20, and 24 hours post TAP)